Address:510 Oakmead Pkwy,SUNNYVALE,CA,94085,US
Device Description : PTS PANELS® Multi-Chemistry Controls contain cholesterol, triglycerides, glucose PTS PANELS® Multi-Chemistry Controls contain cholesterol, triglycerides, glucose, and ketones. The analyte(s) in this solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with the controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each PTS PANELS® HDL Cholesterol Controls contain cholesterol. The analyte(s) in each solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with each set of controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use mater The A1CNow+ Controls™ are supplied in two levels as a frozen, ready-to-use material that requires no reconstitution. The control consists of human whole blood modified to target levels with reagent chemicals to produce the desired reaction when tested by the A1CNow system. Stabilizers and preservatives have been added to maintain shelf life and inhibit microbial growth.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
Device Class :
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CardioChek® PA professional analyzer is intended for in vitro diagnostic use The CardioChek® PA professional analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CardioChek® analyzer is intended for in vitro diagnostic use to test whole b The CardioChek® analyzer is intended for in vitro diagnostic use to test whole blood. The specific analyte measured is determined by the type of test strip chosen.
Device Class : 1
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to moni PTS Panels® Lipid Panel test strips are in vitro diagnostic devices used to monitor total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek® PA or Plus analyzer.
Device Class :
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to moni PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor total cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
Device Class :
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor PTS Panels® glucose test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek brand analyzer.
Device Class :
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes
Device Description : PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
Device Class :
Duns Number: 835772872
Premarket Exempt : No
Prescription Use : Yes